3-ap and gemcitabine as second-line therapy in treating patients with stage iii or stage iv recurrent non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: drugs used in chemotherapy, such as 3-ap and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. giving more than one drug may kill more tumor cells. purpose: this phase ii trial is studying how well giving 3-ap together with gemcitabine as second-line therapy works in treating patients with recurrent stage iii or stage iv non-small cell lung cancer.

objectives: primary * determine the objective response rate in patients with stage iii or iv recurrent non-small cell lung cancer treated with 3-ap (triapine®) and gemcitabine as second-line therapy. secondary * determine the response duration, median time to progression, and overall survival of patients treated with this regimen. * determine the toxicity of this regimen in these patients. * determine the effect of 3-ap (triapine®) on gemcitabine pharmacokinetics and cellular uptake into peripheral mononuclear cells in patients treated with this regimen. outline: this is an open-label, multicenter study. patients are stratified according to participating center. patients receive 3-ap (triapine®) iv over 4 hours and gemcitabine iv over 30 minutes on days 1, 8, and 15\*. treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. note: \*for course 1 only, gemcitabine is administered alone on day 1 and in combination with 3-ap (triapine®) on days 8 and 15. patients are followed every 3 months for up to 2 years. projected accrual: a total of 15-31 patients will be accrued for this study within 7.5-21 months.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed\* non-small cell lung cancer (nsclc) * stage iii or iv disease * one of the following cellular types: * adenocarcinoma * non-diffuse bronchoalveolar cell carcinoma * large cell carcinoma * squamous cell carcinoma note: \*a repeat biopsy of any accessible tumor site is required if \> 5 years have elapsed since the initial diagnosis * progressive disease after 1 prior gemcitabine-containing chemotherapy regimen for stage iii or iv nsclc and must have achieved, at least once, a partial response, complete response, or stable disease during therapy * not a primary non-responder and experienced only progressive disease during gemcitabine-containing chemotherapy * measurable disease * at least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral ct scan * no known brain metastases patient characteristics: age * 18 and over performance status * ecog 0-2 or * karnofsky 60-100% life expectancy * not specified hematopoietic * wbc ≥ 3,000/mm\^3 * absolute neutrophil count ≥ 1,500/mm\^3 * platelet count ≥ 100,000/mm\^3 * no glucose-6-phosphate dehydrogenase (g6pd) deficiency hepatic * bilirubin ≤ 1.5 times upper limit of normal (uln) * alt ≤ 2.5 times uln (5 times uln if liver metastases are present) renal * creatinine ≤ 1.5 times uln or * creatinine clearance ≥ 50 ml/min cardiovascular * no prior uncontrolled cardiac disease * no myocardial infarction within the past 12 months * no symptomatic congestive heart failure * no coronary artery disease * no cardiac arrhythmia pulmonary * no uncontrolled symptomatic pulmonary disease * no pulmonary disease that requires oxygen therapy other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no other malignancy within the past 5 years except completely treated carcinoma in situ of the cervix or nonmelanoma skin cancer * no prior allergic reaction attributed to compounds of similar chemical or biological composition to study agents * no other concurrent uncontrolled illness * no psychiatric illness or social situation that would preclude study compliance prior concurrent therapy: biologic therapy * not specified chemotherapy * see disease characteristics * more than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered endocrine therapy * not specified radiotherapy * more than 4 weeks since prior radiotherapy and recovered surgery * not specified other * no concurrent combination antiretroviral therapy for hiv-positive patients * no other concurrent investigational agents * no other concurrent anticancer agents or therapies

Keywords: recurrent non-small cell lung cancer stage iiia non-small cell lung cancer stage iiib non-small cell lung cancer stage iv non-small cell lung cancer adenocarcinoma of the lung bronchoalveolar cell lung cancer large cell lung cancer squamous cell lung cancer